Institute for Drug and Instrument control

Urunchi, China

Institute for Drug and Instrument control

Urunchi, China
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Nie K.,Xinjiang Medical University | Nie K.,Jinan Cinit Science and Technology Co. | Li L.,Xinjiang Medical University | Li X.,Xinjiang Medical University | And 5 more authors.
Dissolution Technologies | Year: 2010

The aim of this study was to monitor the drug release of ibuprofen sustained-release capsules in real time in situ. A mathematical separation model of dynamic three-wavelength K-ratio spectrophotometry was established to eliminate the interference of gelatin capsule shells when drug release was monitored by a fiber-optic drug dissolution in situ test system. A control experiment with high performance liquid chromatography was performed simultaneously. Within 7 h, real-time drug release profiles were obtained. The average drug release rates were 19.79%, 37.34%, 63.13%, and 88.41% by the fiber-optic drug dissolution in situ test system at the respective time points of 1 h, 2 h, 4 h, and 7 h. There were no significant differences between the in situ and control methods. Drug release of ibuprofen sustained-release capsules can be monitored by the fiber-optic drug dissolution in situ test system assisted by the mathematical separation model of dynamic three-wavelength K-ratio spectrophotometry. Information about the entire dissolution process can be produced by the real-time release profile.

Ying L.,PLA Fourth Military Medical University | Si-Wang W.,PLA Fourth Military Medical University | Hong-Hai T.,Institute for Drug and Instrument Control | Wei C.,PLA Fourth Military Medical University
Pharmacognosy Magazine | Year: 2013

Background: Angelica sinensis is a famous traditional Chinese medicinalherb, which is predominantly used in the treatment of gynecological conditions. It is the first report for the simultaneous determination of six major active components in Chinese Angelica, which is important for quality control. Objective: A validated HPLC-PAD method was first developed to evaluate the quality of crude and processed Radix Angelica through simultaneous determination of six bioactive compounds, namely ferulic acid, senkyunolide I, senkyunolide H, coniferyl ferulate, Z/E-ligustilide and Z/E-butylidenephthalide. Materials and Methods: Samples were separated on a Xtimate ™C18 column (250 × 4.6 mm, 5 μm) and detected by PAD. Mobile phase was composed of (A) aqueous phosphoric acid (0.02%, v/v) and (B) acetonitrile (MeCN) (including 10% tetrahydrofuran, v/v) using a gradient elution. Analytes were performed at 30°C with a flow rate of 1.0 mL/min. Results: All calibration curves showed good linear regression (r2 ≥ 0.9963) within the tested ranges, and the recovery of the method was in the range of 91.927-105.859%. Conclusion: The results demonstrate that the developed method is accurate and reproducible and could be readily utilized as a suitable quality control method for the quantification of Radix Angelica.

Kong A.-Y.,Institute for Drug and Instrument Control | Wu H.,Institute for Drug and Instrument Control | Li J.-L.,Beijing Institute of Pharmacology and Toxicology | Zhang Z.-Q.,Beijing Institute of Pharmacology and Toxicology
Chinese Pharmaceutical Journal | Year: 2016

OBJECTIVE: To study the plasma protein binding rate of decapeptide in several species. METHODS: Ultrafiltration was employed to separate the free and bound decapeptide, acetonitrile was used to precipitate protein, then the plasma concentration of decapeptide by HPLC-MS/MS. RESULTS: The plasma protein binding rates of decapeptide at low, middle and high concentrations (50.0, 100.0, and 800.0 ng·mL-1) were (95.9±1.1)%, (97.40±0.7)% and (94.9±0.6)% in SD rats,(96.8±0.8)%, (97.8±0.2)% and (96.9±0.5)% in Beagle dogs, and (97.3±1.0)%, (98.6±0.2 )% and (96.2±0.9)% in humans, respectively. The average plasma protein binding rate was 96.2% after subcutaneous administration at 200 μg·kg-1 in SD rats. And the average plasma protein binding rate was 97.1% after intramuscular injection at 320 μg·kg-1 in Beagle dogs. CONCLUSION: Decapeptide has potent binding ability to plasma protein in several species. The plasma protein binding rate of decapeptide is independent of its plasma concentrations. Copyright 2016 by the Chinese Pharmaceutical Association.

Liu Y.-E.,Institute for Drug and Instrument Control | Gao C.-S.,Beijing Institute of Pharmacology and Toxicology | Zhong W.,Beijing Institute of Pharmacology and Toxicology
Journal of International Pharmaceutical Research | Year: 2015

The health service of chemical defense medicine is an important guarantee for national security, which has been expanded from dealing with traditional pure chemical warfare to current medical treatment of poisoning caused by public chemical accident, chemical terrorist attack, or future potential toxic agents at the boundary of chemistry and biology. The most recent scientific and technical disciplines, such as synthetic biology, pharmaceutical bioinformatics, nanotechnology, or drug/device combinatorial technology, should be utilized greatly to enhance the ability of the health service of the chemical defense medicine. And it is also important to establish and improve such management practice of emergence medicine as shelf life extension program or emergency use authorization. © 2015, Editorial office of Journal of International Pharmaceutical Research. All rights reserved.

Wang C.,Central South University | Kong A.-Y.,Institute for Drug and Instrument Control | Zhou B.-T.,Central South University | Wang P.,Central South University | And 3 more authors.
Chinese Pharmaceutical Journal | Year: 2015

OBJECTIVE: To establish a method for simultaneous determination of valproic acid(VPA) and 2-propyls-pente-noic acid(4-ene-VPA) in human plasma by gas chromatography-mass spectrometry (GC-MS) to provide a means for monitoring the plasma concentration of VPA and early warning the valproic acid induced liver toxicity. METHODS: The analytes as TMS derivatives by BSTFA +1% TMCS were separated and identified on HP-5MS column(30 m × 0.25 μm, 0.25 mm) by temperature-programming. Split injection mode was used. The analytes spiked in plasma were extracted with ethyl acetate after acidification with NaH2PO4 buffer solution(pH 5) and then determined and identified using selected ion monitoring(SIM) mode and scan mode, respectively. The internal standard method was used for the determination. RESULTS: VPA and 4-ene-VPA were well separated on their SIM chromatograms and also on the total ion current(TIC) chromatograms. The calibration curves for VPA and 4-ene-VPA showed excellent linearity(r > 0.999). Extraction recoveries were higher than 96%. Intra-day and inter-day RSDs were all lower than 2.49% and 4.63%, the lower limit of quantitation is 5.21 and 5.25 ng · mL-1, respectively. The detection limits were 1.6 and 1.5 ng · mL-1, respectively. CONCLUSION: An optimized analytical method for simultaneous analysis of VPA and 4-ene-VPA in plasma are developed using GC-MS. With good accuracy and precision, high extraction recoveries, it is suitable as a means for monitoring the plasma concentration of VPA and early warning the valproil acid induced liver toxicity. In this paper, it is the first time of simultaneously determination VPA and 4-ene-VPA among Chinese people by GC-MS for providing basis for VPA clinical application. Copyright 2015 by the Chinese Pharmaceutical Association.

Li Y.,PLA Fourth Military Medical University | Zhao H.,PLA Fourth Military Medical University | Duan L.-R.,PLA Fourth Military Medical University | Li H.,PLA Fourth Military Medical University | And 4 more authors.
Colloids and Surfaces A: Physicochemical and Engineering Aspects | Year: 2014

The aim of this study was to investigate the potential effect of pectin for liposomal drug delivery systems. An orthogonal L9 (33) test was designed to optimize the preparation condition of cationic bufalin liposomes coated with commercially available citrus pectin (CPL). The change in particle size, zeta potential, entrapment efficiency, stability, mucoadhesion and anticancer effect were evaluated. The results showed that CPL had an excellent stability and mucoadhesive properties, and the drug release in vitro was modest prolonged and sustained. Furthermore, the inhibition effect of liposomes on SW480 colon cancer cells was dramatic enhanced due to a block of cell cycle at G0/G1 phase, and CPL had a higher inhibition rate than bufalin liposomes (BFL) because of the anticancer effect of citrus pectin. It is concluded that CPL is a potentially promising drug carrier system treatment for colon cancer. © 2013 Elsevier B.V.

Kong X.,University of Sichuan | Kong A.,Institute for Drug and Instrument Control
Current Drug Metabolism | Year: 2014

Tea is an infusion of the leaves of the Camellia sinensis plant and is the most widely consumed beverage in the world after water. The main chemical components in teas are phenolic compounds (tea polyphenols, mainly tea catechins). A large number of in vitro and in vivo scientific studies have supported that the tea polyphenols can provide a number of health benefits such as, reducing the incidence of coronary heart disease, diabetes and cancer. Recently, tea polyphenols have proven highly attractive as lead compounds for drug discovery programs. A clear understanding of chemistry, stability, pharmacokinetics and metabolic fate of tea will be significant to elucidate many medicinal effects by biochemical theory and pharmaceutical development. This article reviews the current literature on the pharmacoknetics and biotransformation of tea catechins. The half-lives of tea polyphenols are 2-4h and their absorption and elimination are rapid in humans. The peak times (tmax) are 1 and 3 h after oral administration and the peak plasma concentrations are low μM range. It has been reported that catechins are easily metabolized by enzyme and microbe, and the main metabolic pathways are methylation, glucuronidation, sulfation, ring-fission metabolism, and so on. The information is important to discuss some of the challenges and benefits of pursuing this family of compounds for drug discovery. © 2014 Bentham Science Publishers.

Kong A.,Institute for Drug and Instrument Control | Deng A.,Beijing Normal University | Wu X.,Beijing Normal University | Qiao J.,Beijing Normal University
Journal of Liquid Chromatography and Related Technologies | Year: 2014

Nuflor (florfenicol) Premix for Swine is approved by the U.S. Food and Drug Administration (FDA) and the same regulatory agencies from many other countries for control of swine respiratory disease. A simple and fast LC-MS/MS method for the assay of florfenicol amine, the marker residue of florfenicol in swine muscle is described. A 24-hr strong acid hydrolysis of tissue residues converts florfenicol and its known metabolites into florfenicol amine and also fully releases florfenicol amine from florfenicol residues covalently bound to the swine muscle. The majority of fatty acids and lipids are removed via hexane extraction. Then, the pH of the extracted hydrolysate is adjusted to 11 and florfenicol amine is extracted by ethyl acetate. A portion of ethyl acetate extract is dried under nitrogen and reconstituted with 1 mL acetonitrile. Dispersive solid-phase extraction is used for cleanup in which 100 mg primary secondary amine sorbent is mixed with the extract. After the centrifugation, the supernatant is diluted 20-fold for a hydrophilic interaction LC-MS/MS analysis. No matrix effect is observed in the LC-MS/MS assay and the recovery is nearly 100%. In the comparison with the current US FDA Center for Veterinary Medicine regulatory surveillance method, the new method is simple, fast, and accurate. The validated method is used to investigate the depletion of florfenicol from the swine administrated with Nuflor (florfenicol) Premix. © 2014 Taylor and Francis Group, LLC.

Han J.,302 Military Hospital of China | Lv Q.-Y.,302 Military Hospital of China | Jin S.-Y.,302 Military Hospital of China | Zhang T.-T.,302 Military Hospital of China | And 3 more authors.
Chinese Journal of Natural Medicines | Year: 2014

The anti-bacterial activities of three types of di-O-caffeoylquinic acids (diCQAs) in Lonicera japonica flowers, a traditional Chinese medicine (TCM), on Bacillus shigae growth were investigated and compared by microcalorimetry. The three types of diCQAs were 3, 4-di-O-caffeoylquinic acid (3, 4-diCQA), 3, 5-di-O-caffeoylquinic acid (3, 5-diCQA), and 4, 5-di-O-caffeoylquinic acid (4, 5-diCQA). Some qualitative and quantitative information of the effects of the three diCQAs on metabolic power-time curves, growth rate constant k, maximum heat-output power Pm, and the generation time tG, total heat output Qt, and growth inhibitory ratio I of B. shigae were calculated. In accordance with a thermo-kinetic model, the corresponding quantitative relationships of k, Pm, Qt, I and c were established. Also, the half-inhibitory concentrations of the drugs (IC50) were obtained by quantitative analysis. Based on the quantity-activity relationships and the IC50 values, the sequence of inhibitory activity was 3, 5-diCQA > 4, 5-diCQA > 3, 4-diCQA. The results illustrate the possibility that the caffeoyl ester group at C-5 is the principal group that has a higher affinity for the bacterial cell, and that the intramolecular distance of the two caffeoyl ester groups also has an important influence on the anti-bacterial activities of the diCQAs. © 2014 China Pharmaceutical University.

PubMed | PLA Fourth Military Medical University and Institute for Drug and Instrument Control
Type: | Journal: International journal of nanomedicine | Year: 2014

Liposomes constitute one of the most popular nanocarriers for improving the delivery and efficacy of agents in cancer patients. The purpose of this study was to design and evaluate immunoliposome co-delivery of bufalin and anti-CD40 to induce synergetic therapeutic efficacy while eliminating systemic side effects. Bufalin liposomes (BFL) conjugated with anti-CD40 antibody (anti-CD40-BFL) showed enhanced cytotoxicity compared with bufalin alone. In a mouse B16 melanoma model, intravenous injection of anti-CD40-BFL achieved smaller tumor volume than did treatment with BFL (average: 117 mm(3) versus 270 mm(3), respectively); the enhanced therapeutic efficacy through a caspase-dependent pathway induced apoptosis, which was confirmed using terminal deoxynucleotidyl transferase-mediated dUTP-Fluorescein nick end labeling and Western blot assay. Meanwhile, anti-CD40-BFL elicited unapparent body-weight changes and a significant reduction in serum levels of tumor necrosis factor-, interleukin-1, interleukin-6, interferon-, and hepatic enzyme alanine transaminase, suggesting minimized systemic side effects. This may be attributed to the mechanism by which liposomes are retained within the tumor site for an extended period of time, which is supported by the following biodistribution and flow cytometric analyses. Taken together, the results demonstrated a highly promising strategy for liposomal vehicle transport of anti-CD40 plus bufalin that can be used to enhance antitumor effects via synergetic systemic immunity while blocking systemic toxicity.

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